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Drug, narcotic, or/and medicinal neuropsychotropic substances

Law and regulations

Regulation of the Food and Drug Administration

Re: Collection of fees for information services on adverse reactions resulting from the use of health products, B.E. 2548 (2005)

Notification of Thai Food and Drug Administration Re: Risk-Based Approach Safety Monitoring Program

Guidelines

Guidance for market authorization holders on post-marketing safety reporting for human drugs, narcotics, and medicinal neuropsychotropic substances

Guidelines on monitoring the safety profile of tafenoquine for healthcare professionals in Thailand

Medical device

Law and regulations

Notification of the Ministry of Public Health

Re: Criteria, procedures and conditions for preparation of reports on medical device defects or adverse events occurring to consumers and reports on field safety corrective actions for medical devices, B.E. 2563 (2020)

Notification of the Thai Food and Drug Administration

Re: Prescription of report forms under the Notification of the Ministry of Public Health

Re: Criteria, procedures and conditions for preparation of reports on medical device defects or adverse events occurring to consumers and reports on field safety corrective actions for medical devices, B.E. 2563 (2020)

Guidelines

Guidance for medical device industry: reporting of device defects, adverse events and field safety corrective actions

Guidance for medical device industry on product recall